Reported Dec 4, 2019 · Terminated

BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

    • BALL NOSE GUIDE WIRE 80CM
    • 100CM. Item Nos. 281001080 281001100
  • Product UsageThese instruments and delivery systems are used to facilitate implantation of orthopedic medical devices
Lot codes and dates
  • LOTS

    355 of 355 codes

    • 396280
    • 630880
    • 705620
    • 705640
    • 666290
    • 705650
    • 084760
    • 222820
    • 222830
    • 222840
    • 222850
    • 222860
    • 222880
    • 222890
    • 222900
    • 222910
    • 222920
    • 222930
    • 222940
    • 103057
    • 103058
    • 103059
    • 103061
    • 103062
    • 103063
    • 103064
    • 106566
    • 106567
    • 117023
    • 117024
    • 117026
    • 117027
    • 117028
    • 117029
    • 117030
    • 117032
    • 117033
    • 117033R
    • 117034
    • 135911
    • 135912
    • 135913
    • 135914
    • 135915
    • 135916
    • 135917
    • 135918
    • 164597
    • 164598
    • 164606
    • 164607
    • 164611
    • 164612
    • 206297
    • 206298
    • 206299
    • 206300
    • 206301
    • 206302
    • 206303
  • FA4AK7A NXV7113R Y5XAP7000 ZV8AE7 UDI(01)00887868027857(17)231009(10)396280 (01)00887868027864(17)231016(10)830520
Amount recalled
1729

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 21, 2021 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.